N/A
N=15
An Open-Label, Multi-Center, Clinical Study Evaluating the Effect of the NDE L68 StableFit® Punctal Plug on the Tear Lake
Dry Eye Syndromes
Bottom Line
View on ClinicalTrials.gov: NCT04280653 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Investigators' Evaluation of the Tear Lake; Comparison of Baseline Result to 7 Days — 129 mean percent change from baseline
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- NDE L68 StableFit® Punctal Plug (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mati Therapeutics Inc.
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Investigators' Evaluation of the Tear Lake; Comparison of Baseline Result to 7 Days |
129 | — |
| PRIMARY Investigators' Evaluation of the Tear Lake; Comparison of Baseline Result to 28 Days |
143 | — |
| SECONDARY Investigator's Evaluation of the Subject's Acceptance of the NDE L68 StableFit® Punctal Plug, Comparison of Baseline Result to 28 Days |
— | — |
Summary
To evaluate the effect of the NDE L68 StableFit® punctal plug on the tear lake.
Eligibility Criteria
Inclusion Criteria
- A male or female subject, 18 years of age or older, in good general health at the time of the baseline examination, who may or may not have a mild to moderate dry eye condition
- A subject must be able to read, comprehend and be willing to give HIPAA authorization and informed consent
- A subject must be willing to have a punctal plug inserted in the lower punctum of one of their eyes
- A subject must be willing to comply with all study instructions, agree to make all office appointments, and complete the entire course of the study
Exclusion Criteria
- A subject with a history of complications, adverse events, trauma or disease in the nasolacrimal area, whether or not it was due to punctal plug wear, including but not limited to dacryocystitis, inflammation or canaliculitis in the planned study eye
- A subject with a history of intolerance to punctal plugs
- A subject with structural lid abnormalities (e.g., ectropion, entropion) in the planned study eye
- A subject with any clinically significant lid, conjunctival or corneal findings in the planned study eye at the baseline visit
- A subject with a severe dry eye condition
- A subject experiencing epiphora in the planned study eye
- A subject experiencing any clinically significant ocular pain or discomfort in or around either eye at the baseline visit
Data sourced from ClinicalTrials.gov (NCT04280653). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.